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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
February
21, 2024
Date
of Report (Date of earliest event reported)
Enveric
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38286 |
|
95-4484725 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
Enveric
Biosciences, Inc.
4851
Tamiami Trail N, Suite 200
Naples,
FL 34103
(Address
of principal executive offices) (Zip code)
Registrant’s
telephone number, including area code: (239) 302-1707
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, par value $0.01 per share |
|
ENVB |
|
The
Nasdaq Stock Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
February 21, 2024, Enveric Biosciences, Inc. (the “Company”) published a press release announcing a library of preclinical
compounds across seven distinct molecule classes targeting mental health disorders. A copy of such press release is attached hereto as
Exhibit 99.1 and is incorporated by reference herein. The Company undertakes no obligation to update, supplement or amend the materials
attached hereto as Exhibit 99.1.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in
such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute
a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination
of such information is required by Regulation FD.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date:
February 21, 2024 |
ENVERIC
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Joseph Tucker |
|
|
Joseph
Tucker |
|
|
Chief
Executive Officer |
Exhibit
99.1
Enveric
Biosciences Unveils Library of Preclinical Compounds Across Multiple Distinct Molecule Classes Targeting Mental Health Disorders
Novel
compounds protected under Enveric’s intellectual property portfolio provide potential licensing opportunities and non-dilutive
revenue streams.
CAMBRIDGE,
Mass., February 21, 2024 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology
company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety,
and addiction disorders, today announced the discovery of multiple, promising novel compounds sourced using the company’s Psybrary™
platform and proprietary computational chemistry and artificial intelligence (AI) drug-discovery system (PsyAI™). The novel compounds
span seven distinct molecule classes totaling at least 57 unique product opportunities, all of which are protected by Enveric’s
expansive intellectual property portfolio and represent potential out-licensing opportunities and non-dilutive revenue streams for the
Company.
Together,
the novel and distinct molecule classes broaden and deepen Enveric’s library of assets targeting difficult-to-address mental health
disorders, adding to its lead candidate EB-003, a first-in-class neuroplastogen designed to eliminate hallucinations, and EB-002, formerly
EB-373, a next generation synthetic prodrug of the active metabolite, psilocin.
“Our
ability to identify EB-003 and EB-002 as our lead drug candidates was the result of an extensive process in which our research team analyzed
more than one thousand compounds spanning numerous classes of molecules, utilizing our proprietary PsyAI and Psybrary platforms,”
said Joseph Tucker, Ph.D., Director and CEO of Enveric. “As a result, Enveric now possesses what we believe to be one of the most
diverse portfolios of potential drug molecules for the treatment of key, underserved mental health and neurological disorders. Our dedicated
approach to protecting our discoveries should enable us to generate significant near- and long-term value for our shareholders via potential
partnering and/or licensing agreements.”
The
novel compounds span seven diverse molecule classes and subclasses, including:
| ● | Novel
Serotonin-Norepinephrine-Dopamine Reuptake Inhibitors (SNDRI) |
| ○ | Also
known as triple reuptake inhibitors (TRIs), SNDRIs are an emerging class of medications designed
to treat severe depression and anxiety disorders. |
| ○ | Enveric
SNDRI compounds show strong binding to serotonin transporter (SERT), norepinephrine transporter
(NET) and dopamine transporter (DAT). |
| ○ | Enveric
SNDRI compounds also demonstrate distinct additional serotonin receptor binding profiles
that bear similarities to those of the antidepressant Nefazodone and the anxiolytic Buspirone. |
| ● | Non-selective
Serotonin Reuptake Inhibitor (NSRI) |
| ○ | Enveric
NSRI compounds show strong binding to SERT, as well as to the 5-HT1A receptor, known to be
a therapeutically valuable target. |
| ○ | Certain
of Enveric’s NSRIs demonstrate additional binding to various serotonin and dopamine
family receptors, with binding profiles similar to the antidepressant Vortioxetine and the
atypical antipsychotic Aripiprazole. |
| ● | Novel
MDMA Derivatives (EMD) Series |
| ○ | Twenty
novel MDMA derivatives are separated into three subgroups: Strong 5-HT2A receptor binding,
Weak 5-HT2A binding, and No 5-HT2A receptor binding. Current literature indicates agonism
of the 5-HT2A receptor is linked to hallucination in humans and also to the induction of
neuroplasticity. |
| ○ | Each
subgroup of Enveric’s novel MDMA derivatives demonstrates unique and expanded receptor
binding activity targeting adrenergic and/or dopaminergic receptors as well as epinephrine/norepinephrine
family receptors. Some of the resulting receptor binding profiles are similar to the anxiolytic
Buspirone, the antiepileptic Fenfluramine, the ADHD drug Guanfacine, and the atypical antipsychotic
Aripiprazole. |
| ● | Bifunctional
Psilocin Prodrugs (BPP) |
| ○ | BPPs
are readily absorbed, detectable in plasma, and converted to therapeutically relevant levels
of plasma psilocin, with demonstrated lower Head Twitch Response (HTR) relative to psilocybin
in mice; HTR is reported in the literature to be a predictive indicator for hallucination
in humans. |
| ○ | Each
BPP parent prodrug demonstrates its own unique binding profile to serotonin 5-HT1A receptor,
5-HT1B receptor and SERT, with similarities to anxiolytics Buspirone, antidepressant/anxiolytic
Flesinoxan, and the antidepressant Paroxetine. |
| ● | Novel
Psilocin Prodrug (NPP) Series |
| ○ | NPPs
are designed to be metabolized to release therapeutic levels of systemic psilocin at varying
rates, providing treatment regimen optionality. |
| ○ | Included
in this series are four compounds that can be converted upon direct intravenous injection
to psilocin: potentially bypassing the need for first-pass metabolism, making them amenable
to non-oral forms of administration (e.g. intranasal, sublingual, buccal). |
| ● | Melatonin-Receptor
Agonist (MRA) Series |
| ○ | Melatonin,
a natural indolamine, is essential for regulating circadian rhythm in mammals and is often
used in to treat a variety of sleep disorders. |
| ○ | Enveric
MRA compounds demonstrate strong binding to the MT1 Melatonin receptor with some being highly
selective for MT1 while others demonstrate expanded target binding profiles similar to the
antidepressants Agomelatine, Vortioxetine, Imipramine, and Trazodone. |
| ● | Neuroplastogenic
Antidepressant (NAD-01) |
| ○ | Designed
to induce neuroplasticity and promote long-term therapeutic benefit in patients suffering
from severe depressive mood disorders. |
| ○ | Demonstrates
neuroplastogenic activity comparable to known 5-HT2A receptor agonist N,N-Dimethyltryptamine
(DMT). |
| ○ | Demonstrates
weak 5-HT2A receptor binding affinity and activation. |
| ○ | Produces
lower Head Twitch Response relative to psilocin and DMT, while promoting recovery of sucrose
preference (SP) in stressed mice - an accepted model for evaluation of antidepressant activity. |
For
more information about Enveric’s novel preclinical compounds spanning multiple, distinct classes of molecules, please visit: https://www.enveric.com/psybrary.
About
Enveric Biosciences
Enveric
Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics
for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™,
Enveric has created a robust intellectual property portfolio of New Chemical Entities for specific mental health indications. Enveric’s
lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote
neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation
synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered
in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.
Forward-Looking
Statements
This
press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These
statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking
statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology
such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,”
“budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates”
or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases
which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements
may include historical statements and statements regarding beliefs, plans, expectations, or intentions regarding the future and are based
on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ
materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the
ability of Enveric to: carry out successful clinical programs in Australia; achieve the value creation contemplated by technical developments;
avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials;
establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals
to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up
manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists;
secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes
to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
A
discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings
with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future
events or otherwise, except as required by law.
Contact
Investor
Relations
Tiberend
Strategic Advisors, Inc.
Daniel
Kontoh-Boateng
(862)
213-1398
dboateng@tiberend.com
Media
Relations
Tiberend
Strategic Advisors, Inc.
Casey
McDonald
(646)
577-8520
cmcdonald@tiberend.com
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